At the turn of the 21st century, obesity is the epidemic with the greatest prevalence and incidence in the United States. Obesity is defined as having a body mass index (BMI)≧30 kg/m2, and morbid obesity, or clinically severe obesity, is defined as having a BMI≦40 kg/m2, or a BMI≦35 kg/m2 with co-existing comorbid conditions. It is estimated that there are approximately 20 million people in the United States who are morbidly obese.
Obesity is not primarily a cosmetic problem. Obesity and morbid obesity are associated with: hypertension; atherosclerotic cardiovascular disease (coronary, cerebral, and peripheral); hypercholesterolemia; type 2 diabetes; asthma; obstructive sleep apnea; gallstones; cirrhosis and carcinoma of the liver; carcinoma of breast and uterus; low-back syndrome and herniated disks; weight bearing osteoarthritis of the hips, knees, ankles, and feet; lower extremity edema and varicosities; thrombophlebitis and pulmonary emboli; skin fold rashes; and many other diseases. Furthermore, in our society, the obese and morbidly obese have psychological, social, marital, and sexual problems. Obesity is also an economic problem associated with denial of employment, restriction of career advancement and higher educational opportunities, and uninsurability or high insurance premiums.
Unfortunately, medical diet and drug therapy today may not be as effective as desired with respect to obesity, and most certainly morbid obesity. This disease has, however, definitively been shown to respond to bariatric or obesity surgery.
Bariatric surgery can be divided by mechanisms of action into four categories: malabsorptive, malabsorptive/restrictive, restrictive, and other procedures and approaches. Adjustable gastric banding, laparoscopic or non-laparoscopic, is restrictive in intent. The restrictive procedures of bariatric surgery can be performed more rapidly and are more physiological than any of the other bariatric procedures, since, as a rule, no part of the gastrointestinal tract is resected, bypassed, or rerouted.
In the last few years, gastric banding has become a dominant force in bariatric surgery operative technology, and has fairly well displaced the stapled and banded gastroplasty. It is the most utilized bariatric procedure in Europe and Australia and, though still second to gastric bypass, is gaining in popularity in the United States.
Adjustable gastric band placement is usually performed laparoscopically but could be performed by open or endoscopic surgery. This intervention creates a restriction of the upper gastric lumen, effectively separating the gastric lumen into a small (approximately 15 ml) upper pouch and the remainder of the gastric lumen, the gastric remnant. The gastric band's constriction of the upper gastric lumen and, therefore, its ability to regulate gastric flow to control food intake, is a function of adjustable inflation of the lumen of the band via a catheter and a subcutaneous port. There are different and patented engineering concepts for the construction of the different adjustable gastric bands, the catheters and ports, and the filling techniques. To the best of the inventors' knowledge, there are no existing patents or disclosures for directly determining the lumen size, diameter, or volume enclosed by the gastric band in a patient and, thereby, determining the unrestricted flow path for luminal contents, i.e., food.
Weight loss success of adjustable gastric banding, to a major degree, resides in follow-up care after band placement. Follow-up care is primarily a function of obtaining, maintaining, or adjusting the gastric lumen size of the gastric pathway through the constricting band. Optimal gastric lumen size provides for food restriction in comfortable balance with food intake, leading to a hypocaloric state and weight loss. To achieve this state, it is necessary to adjust the intraband fluid volume using the band's catheter and port or other mechanism.
This gastric lumen adjustment needs to take place up to or beyond six times per year, especially in the first year after band placement. The band volume adjustment is performed by a physician or a skilled nurse guided by the patient's subjective sensations of fullness or discomfort; expensive, radioactive exposure to x-rays and/or fluoroscopy; or newer technology equating intraband pressure with optimal gastric lumen size. None of these methods measures directly the gastric lumen size of the band and the size (diameter or volume) of the intragastric conduit within the encircling band. There is today no available technology directly to measure these parameters of gastric lumen size, and, thereby, determine the optimal adjustment of the intraband volume and constriction of the gastric lumen. Gastric band efficacy for each individual patient would be optimized if the gastric lumen size parameters could be directly measured. It may also be feasible to determine a formula or algorithm for gastric lumen size adjustment useable in adjustable gastric band patients as a class.
In summary, utilization of our method may allow for optimization of gastric lumen size adjustment and provide for comfortable weight loss with the adjustable gastric band, placed laparoscopically or nonlaparoscopically, and weight loss results beyond those achievable today, as well as enhanced patient satisfaction.
Gastric bands are described in U.S. Pat. Nos. 5,938,669, 6,210,347, 6,676,674, and 7,338,433, the entire contents of each being expressly incorporated herein by reference.
The art referred to and/or described above is not intended to constitute an admission that any patent, publication or other information referred to herein is “prior art” with respect to this invention.
All US patents and applications and all other published documents mentioned anywhere in this application are incorporated herein by reference in their entirety.
Without limiting the scope of the invention, a brief summary of some of the claimed embodiments of the invention is set forth below. Additional details of the summarized embodiments of the invention and/or additional embodiments of the invention may be found in the Detailed Description of the Invention below.
A brief abstract of the technical disclosure in the specification is provided for the purposes of complying with 37 C.F.R. §1.72.